June 2012 | Volume 11 | Issue 6 | Features | 778 | Copyright © June 2012
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department
may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In
addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
Fibrocell Science, Inc. has announced that clinical trial data
demonstrating the effectiveness of LAVIV™ (azficel-T) for the
improvement of the appearance of moderate-to-severe nasolabial
fold wrinkles has been published online by Dermatologic
Surgery and will also be published in an upcoming print issue.
LAVIV is an aesthetic treatment made from the patient's own
living, cultured, collagen-producing fibroblast cells and then injected
into smile-line wrinkles.
The publication in Dermatologic Surgery includes the combined
results of two identically-designed, Phase III, multi-center,
randomized, double-blind, placebo-controlled, studies of 421
patients that showed statistically significant efficacy results
for LAVIV. The criteria for a positive response were a 2-point
improvement on the Subject Wrinkle Assessment Scale and a
2-point improvement on the Evaluator Wrinkle Assessment Scale
for both nasolabial fold wrinkles. 30% of subjects who received
at least one LAVIV injection had a 2-point improvement in the
appearance of smile lines 6 months after completing treatment,
as rated by investigators, versus 8% for placebo. In self-assessments,
59% of patients reported a 2-point improvement six
months after completing treatment, versus 26% for placebo.
The patented technology behind LAVIV is an advanced process
that extracts a person's fibroblast cells from a small skin sample
and multiplies them in the Fibrocell Science lab. In normal skin,
fibroblasts are responsible for producing collagen. LAVIV is the
resulting formulation of a person's own living, cultured, fibroblast
cells, which is then injected into smile-line wrinkles. Each
person's formulation of LAVIV is unique because it is made from
his or her own fibroblast cells.
LAVIV was approved by the FDA on June 21, 2011 for the improvement
of the appearance of moderate-to-severe nasolabial
fold wrinkles in adults and is the only personalized cell therapy
approved by the FDA for aesthetic use.
PreCision Dermatology Acquires Assets of Triax
PreCision Dermatology recently announced that it has acquired
the assets of Triax Pharmaceuticals, LLC. Triax carries dermatology
products such as Locoid®, Minocin®, and Tretin-X™. Onset
Dermatologics, a subsidiary of PreCision Dermatology, will now
market these products.
FDA Cleared Excellagen
Cardium Therapeutics has recently exhibited its FDA-cleared
Excellagen®. This is a wound care product that is carried in a syringe and is used in the treatment of diabetic foot ulcers, pressure
ulcers, and other dermal wounds.
Excellagen® is a fibrillar collagen-based topical gel (2.6%) that has a
high molecular weight bovine Type I collagen. This gel is supplied in
pre-filled syringes, which are then applied topically to the treatment
area by a physician. It promotes a favorable wound-healing environment
and requires re-application every 1 to 2 weeks. One syringe
with 0.5 cc of Excellagen® covers wounds up to 5cm2 in size.
FDA Denies Approval for Pliaglis
Nuvo Research, Inc. recently announced that the topical local anesthetic
cream Pliaglis was denied approval by the FDA. Pliaglis
was originally developed by Zars Pharma, Inc. and was approved
by the FDA in 2006 for topical local analgesia for superficial dermatologic
procedures including laser treatments and dermal filler
injections. In 2007, Galderma Pharma, S.A. was given promotion
and distribution rights for Pliaglis and Galderma voluntarily removed
it from the US market in 2008 due to manufacturing issues.
Once these manufacturing issues were resolved, Galderma filed
a supplemental New Drug Application for Pliaglis; however, this
approval was unsuccessful.
Lutronic, Inc. recently announced that the FDA has granted
clearance for marketing of the ADVANTAGE® diode hair removal
laser. Millions of laser hair removal procedures are
performed annually. Lutronic states that the ADVANTAGE Laser
is faster and more efficacious than other lasers. It does this
by using a larger spot size that reduces treatment time. ADVANTAGE
allows operators to adjust both the fluence and pulse
widths to customize treatments for each patient.
FDA Warning Regarding Mercury
The FDA recently notified health care professionals and warned
consumers regarding mercury that may be contained in certain
skin creams, soaps or lotions. These products are sold illegally
in the United States after being manufactured abroad. They are
marketed as skin lighteners and anti-aging treatments. Investigations
by the FDA have revealed at least 35 products with levels of
mercury that are too high.
The FDA warns that consumers should check labels of skin
lightening or anti-aging products for “mercurous chloride,
calomel, mercuric, mercurio, or mercury.” If any of these ingredients
are present, consumers should discontinue use of the